BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2822441 · Received June 7, 2012

    Report

    Report Number
    3004939290-2012-00134
    Event Type
    Injury
    Date Received
    June 7, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A FEMALE PT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE BIFURCATION USING A 6F SHEATH (MODEL UNK). A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED NO VISIBLE PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PT EXPERIENCED 10-15 MINUTES POST PROCEDURE A HEMATOMA IN HER INNER THIGH. THE HEMATOMA WAS DESCRIBED AS APPROXIMATELY 10 CM IN SIZE. ALLEGEDLY, THE HEMATOMA SUBSIDED AFTER 15 MINUTES OF MANUAL COMPRESSION. THE PT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO REPORTED CLINICAL SEQUELA. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HEPARIN